pedicle screw misplacement malpractice11 Apr pedicle screw misplacement malpractice
Operative information including fusion level, number of levels fused, level of misplaced screw(s), single versus multiple misplaced screw(s), presence of known CSF leakage, and primary injury due to screw misplacement was also collected. Malpractice liability and defensive medicine: a national survey of neurosurgeons. This study quantifies the rate of screw misplacement on a per-patient basis to highlight its effect on potential morbidity. Intraoperative pedicle fractures requiring further points of fixation. Spine 13:952953, 1988. 18. Determining legal responsibility in otolaryngology: a review of 44 trials since 2008. The median time to case closure was 56.3 (35.267.2) months when ruled in favor of the plaintiff (i.e., patient) compared to 61.5 (51.477.2) months for defendant (surgeon) verdicts (p = 0.117). 2014;75(6):609613. Overall reported screw misplacement is low, but it does not reflect the potential impact on patient morbidity. and transmitted securely. J Neurosurg Spine. Krag MH, Beynnon BD, Pope MH, et al: An internal fixator for posterior application to short segment of the thoracic, lumbar, or lumbosacral spine. Long spine fixation was necessary for patients with tuberculous spondylitis and metastatic disease. However, the misplacement of pedicle screws can lead to disastrous complications. 1. Don't jump in get legal help. Several studies reveal that fusion rates increase when rigid internal fixation is used, 14,20,21,33,38 and that by using pedicle screws and plates or rods for stabilization, spinal arthrodesis can be limited to the disease segments. Malpractice litigation and the spine: the NHS perspective on 235 successful claims in England. Elsamadicy AA, Sergesketter AR, Frakes MD, Lad SP. Similarly, the highest inflation-adjusted amount awarded ($2,302,472) for pseudarthrosis was attributed to a medially breached pedicle screw during an L5S1 fusion that was determined to have caused the failed union and subsequent need for revision surgery. 19. West et al 33 also reported a 29% complication rate for the first 50 patients and a 26% complication rate for the last 74 patients. Rev Chir Orthop Reparatrice Appar Mot 62:151160, 1976. Epub 2014 Jun 13. FOIA Disclaimer. Jury awards $4.5M over misplaced pedicle screw during spine surgery: 5 things to know Spine Monday, May 7th, 2018 Post Listen Text Size On April 6, a Union County, N.J., jury awarded a plaintiff $4.5 million over a botched spine surgery. Dr. Goodwin has received grants from the Burroughs Wellcome Fund, North Carolina Spine Society, and Robert Wood Johnson Harold Amos Medical Faculty Development Program and the NIH/NINDS K12 NRCDP Physician Scientist Award. Misplaced pedicle and lateral mass screws result in a considerable risk of malpractice litigation against spine surgeons. National Library of Medicine Please try after some time. Epub 2014 Apr 4. 2014;20(2):196203. 2011;365(7):629636. In 2 patients, misplacement of pedicle screws was recognized intraoperatively and all implants were removed. A total of 2396 screws were placed accurately (87.96%). Spine surgery has been disproportionately impacted by medical liability and malpractice litigation, with the majority of claims and payouts related to procedural error. Bydon M, Xu R, Amin AG, et al. Analysis and interpretation of data: Sankey, TT Than. McLaughlin WM, Donnelley CA, Yu K, Gillinov SM, Tuason DA. 2002;27(22):24252430. Makhni MC, Park PJ, Jimenez J, et al. 30. Edmunds I, Cummine J, Fearnside M: Prevention of dislodgement of Cotrel-Dubousset rods from tulip screws. and 17.1% of the patients included had at least one screw misplaced. 33. Spine neurosurgeons facing the judicialization of their profession: disenchantment and alteration of daily practicea qualitative study. In several of the studies in the spinal literature, the contention that instrumentation improves arthrodesis rates, considering that nonunion contributes to a poor outcome in spinal arthrodesis is favored. In the current series, there were no cases of screw misplacement or vascular or neurologic complications caused by implant application. Thankfully, most screws are just misplaced by a millimeter or two out the front or are slightly off medially, so they are not doing real damage. However, despite the apparent widespread use of pedicle system fixation, few studies of problems and particularly complications have been published. Summary of background data: The medical malpractice suit Ayala v. Friedlander, M.D., claimed that a March 2011 lumbar fusion surgery performed by neurosurgeon Marvin Friedlander, MD, and orthopedic spine surgeon Douglas Bradley, MD, strayed from the accepted standards of care because a pedicle screw was placed in the wrong location. $ = US$. Epub 2022 Oct 29. Segal J. Dr. Shaffrey holds patents with, receives royalties from, and is a consultant for Medtronic, NuVasive, and Zimmer Biomet; is a stockholder in NuVasive; is a consultant for K2M, Stryker, SI Bone, and In Vivo; and has received grants from the ISSG, DePuy Synthes, and AO Spine. Methods. It argued that the foot drop was unavoidable and due to the surgeons need to manipulate the right L5 nerve root in order to remove Nyquists herniated disc during the spinal fusion surgery. Todd NV. Ann R Coll Surg Engl. Hecht N, Kamphuis M, Czabanka M, et al. The https:// ensures that you are connecting to the Illinois Jury Finds in Favor of Doctor in Gallbladder Surgery that Led to Fatal Bowel Perforation Nickl v. Barry S. Rosen, M.D. The development of the transpedicle screw has provided control of the vertebral motion segment in each plane, resisting any type of load. Copyright 2023 Becker's Healthcare. One of the patients had a late wound infection develop that was treated by radical debridement and removal of instrumentation. Conception and design: Sankey, KD Than. Examples of both laterally and medially misplaced lumbar pedicle screws are provided in Fig. The defendants explanation provided an explanation for why Nyquists foot drop did not resolve after the misplaced screw was removed and shed doubt on the plaintiffs theory of liability. 1. Spine 18:983991, 1993. Disc space narrowing was the most common problem after instrumented arthrodesis and was observed in 27 patients (24.1%). Federal government websites often end in .gov or .mil. The plaintiff will recover $2.25 million because of a high-low agreement the lawyers entered after closing arguments, the New Jersey Law Journal reports. Department of Neurosurgery, Spine Division, Duke University Medical Center, Durham, North Carolina; and, Malpractice liability and defensive medicine: a national survey of neurosurgeons, Defensive medicine among high-risk specialist physicians in a volatile malpractice environment, Defensive medicine: a culprit in spiking healthcare costs, Incidence and costs of defensive medicine among orthopedic surgeons in the United States: a national survey study, Defensive medicine in U.S. spine neurosurgery, Personal consequences of malpractice lawsuits on American surgeons. Pedicle screw insertion in the thoracolumbar spine. The defense pointed to the lack of evidence that the screw had ever come into contact with the L5 nerve root. SECTION I SYMPOSIUM: Advances in Spine Surgery, Distribution of Spinal Disorders in 112 Patients, Classification of Complications in 64 patients. Over 40% of patients had screws with either some/major concern. 2016;102(2):358362. Drs. Subjects were 10,754 patients (73,777 pedicle screws) who underwent PSF at 11 hospitals over 15 years. The average followup was 35 months (range, 1851 months). Ultimately, no significant differences in case demographics were found between plaintiff and defendant judgments (Table 1). Spine 13:10121018, 1988. It should be used by experienced and qualified surgeons who are aware of the pitfalls associated with its use. Study design: 20th Annual Spine, Orthopedic & Pain Management-Driven ASC Conference, 8th Annual Health IT + Digital Health + RCM Conference, 29th Annual Meeting - The Business & Operations of ASCs, The issues spine surgeons are advocating for outside of the operating room, Centinel Spine is now covered by all major payers, What's next for SI joint fusion? Patient safety: disclosure of medical errors and risk mitigation, Neurosurgical practice liability: relative risk by procedure type. Pedicle screw placement accuracy using ultra-low radiation imaging with image enhancement versus conventional fluoroscopy in minimally invasive transforaminal lumbar interbody fusion: an internally randomized controlled trial. Nyquist had requested the defendants offer, which in retrospect was perhaps a poor decision in light of the Kane County jurys verdict. PLoS One. Placement of the pedicle screws in the thoracolumbar and lumbar spine is a technically demanding procedure. A misplacement rate of more than 20 % (129 misplaced screws out of 608) seems to be unacceptable compared to only 4.5 % misplacements when using CT-navigation leading to the conclusion that pedicle screw instrumentation in the middle and upper thoracic area should be carried out with the help of navigation only. your express consent. This was followed by pseudarthrosis requiring revision surgery, present in 14.3% (n = 3) and 14.9% (n = 7) of plaintiff- and defendant-awarded cases, respectively (p = 0.99). 16,24,28 Simultaneously, the evolution of the surgical techniques has led to increased procedural safety. Harrington and Tullos 11 first reported the technique of transpedicle screw fixation, and Roy-Camille et al 23 popularized the first practical method of pedicle screw fixation. Lehmann TR, LaRocca HS: Repeat lumbar surgery: A review of patients with failure from previous lumbar surgery treated with spinal canal exploration and lumbar spine fusion. PMC Accuracy of fluoroscopically-assisted pedicle screw placement: analysis of 1,218 screws in 198 patients. Rajasekaran S, Bhushan M, Aiyer S, et al. These numbers are in line with the current literature. to maintaining your privacy and will not share your personal information without Clinical Orthopaedics and Related Research411:86-94, June 2003. The highly litigious environment within healthcare has resulted in a majority of physicians practicing defensive medicine,15 often leading to burnout6,7 and an exorbitant ethical and financial burden on medical and surgical care.7,8 In 2008, medical liability accounted for $55.6 billion, representing 2.4% of the United States (US) healthcare expenditures that year,5,7,9,10 and the pervasive practice of defensive medicine may cost up to $210 billion annually in the US.5 A similar trend has been observed in Europe.11, Neurosurgery is the specialty most frequently affected by lawsuits and the fear of litigation, both in the US and abroad,12 with spine surgery at the forefront.11,1317 As a result, spine surgeons are nearly three times more likely than nonspine surgeons to practice defensive medicine, defined as the avoidance of high-risk procedures and the provision of unnecessary services and assessments beyond what is clinically necessary in an effort to avoid litagation.5 The average time to judgment in a case is approximately 5.1, 5.0, and 3.4 years for defendant verdicts, plaintiff rulings, and settlements, respectively.7,15 As a result, physicians spend an average of 11% of their careers dealing with one or more open malpractice claims.18 Neurosurgeons are especially impacted, spending an average of 27.2% of their careers in an open lawsuit.10. Placement of thoracolumbar pedicle screws using three-dimensional image guidance: experience in a large patient cohort. The medicolegal landscape of spine surgery: how do surgeons fare? official website and that any information you provide is encrypted As part of the surgery, Dr. Taras Masnyk inserted four metal screws into the plaintiff's spine. Complications were classified as general, hardware-related, problems associated with the instrumented segments, junctional level problems, and problems related with balance (Table 2). Among the plaintiff-awarded cases, 13 (61.9%) were decided by jury trial, 7 (33.3%) by settlement, and 1 (4.8%) by arbitration. 2017 Mar;5(2):109-116. doi: 10.1016/j.jspd.2016.10.007. Jena AB, Seabury S, Lakdawalla D, Chandra A. 1,12,19,22 The largest series of adjacent segment breakdown was reported by Schlegel et al. Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders. Neurosurgical practice liability: relative risk by procedure type. J Bone Joint Surg 61A:201207, 1979. 2012 Feb 1;37(3):E188-94. Whitecloud et al 35 reported an overall 45% rate of minor and major complications, with the rate of complications increasing to 63% in patients who had previous lumbar surgery. Malpractice issues in neurological surgery. Taylor CL. J Neurosurg Spine. It has a great developing technique that is used for fixation and fusion in spine surgery. 17,18,31,39 Edwards 6 showed that solid arthrodesis developed in 96% of patients without previous surgery, whereas 84% of patients having secondary operations experienced a similar result. J Spine Surg. Introduction. Through the use of expert witness testimony, Mr. da Costa was able to prove to the jury that by misplacing the pedicle screw during the surgery, and failing to timely diagnose and correct the malpositioned screw, Defendants deviated from accepted standards of care. 2016;25(3):716723. Lali Sekhon, Jocelyn Idema & more: 4 spine and neurosurgeons making headlines, Spinal cord stimulation trumps medication for pain reduction 7 takeaways, Dr. Khalid Kurtom on major trends in spinal cord injury surgery. Spine 17:834837, 1992. leg pain. The states with the most cases included California (n = 10, 14.7%), New York (n = 6, 8.8%), Pennsylvania (n = 6, 8.8%), and Illinois (n = 5, 7.3%; Table 2). However, the misplacement of pedicle screws can lead to disastrous complications because of the close proximity to neural tissue and the surrounding vessels, although rare, serious complications have been reported, such as dural tear, nerve-root irritation, neural injury . Hsu K, Zucherman JF, White AH: Internal Fixation With Pedicle Screws. Moreover, several cases stated that the surgeon used only the anteroposterior or the lateral view, but not both, and the plaintiffs counsel used this information in support of their claim. Nevertheless, research has shown that screws are misplaced in approximately 14%55% of cases using the standard techniques (freehand and 2D fluoroscopic guidance) employed by most spine surgeons,21,33 resulting in injury in approximately 1%8% of cases.21 In addition to the avoidable procedural risk to the patient, each misplaced screw carries the threat of future litigation, as reported above. Similar to our findings, prior studies have shown that settlements result in lower payouts than cases that are ultimately taken to trial,7,14,15,30 with awards ranging from $125,000 to $9,000,000 compared to $134,000 to more than $38,000,000.7,15 Nevertheless, the true financial toll on spine surgery is largely unknown given that 85% of cases are dismissed or settled out of court, with undisclosed amounts.14 Likewise, substantial time is spent and costs, including legal and administrative, are incurred before judgment, as noted above. Administrative/technical/material support: Mehta, Wang, KD Than. All Rights Reserved. HHS Vulnerability Disclosure, Help There were nine instrumentation failures at the thoracolumbar area (seven patients), lumbar area (one patient), and lumbosacral area (one patient). The initial search using the terms above returned 3654 cases. We also investigated the effect of bone mineral density (BMD), diameter of pedicle screws, and the region of spine on the pullout strength of pedicle screws. Malpractice litigation following spine surgery. Acquisition of data: Sankey. A total of 47 (69.1%) cases resulted in a decision for the defendant and 21 (30.9%) for the plaintiff. 6 Defensive medicine in U.S. spine neurosurgery. Quraishi NA, Hammett TC, Todd DB, et al. Insuring spinal neurosurgery. 2017;27(4):470475. Fager CA. Cook County Surgeons Cut Common BIle Duct During Surgery, But Jury Finds for Defendants Irwin v. Alan Loren, M.D. Although the rate of the reported medical complications was high (36.5%), these did not significantly affect the final clinical outcome of the current patients. Acta Neurochir (Wien). 2018;29(4):397406. Debate Over Extent of Eye Damage Following Implant Lens Surgery Leads to $1 Million Verdict in Zaleski v Elmhurst Eye Surgery Center. Can Postoperative Radiographs Accurately Identify Screw Misplacements? Orthop Trans 11:99, 1987. Dr. Shaffrey has received grants from the NIH and Department of Defense. The pedicle screw system is widely used in spine surgery, and it provides rigid fixation and leads to successful subsequent deformity correction and bony fusion. 2012;41(2):6973. J Neurosurg. The median time to case closure was longer for defendant-awarded cases, but this finding was not statistically significant (61.5 vs 56.3 months, p > 0.05). In the current study, no incidence of bent and broken screws or tulip screw plug dislodgement necessitated additional treatment, and all the patients achieved solid fusion despite the failure of instrumentation. What can spine surgeons do to improve patient care and avoid medical negligence suits? Although the rate of the reported complications was high, the final outcome of the patients was not affected significantly. One common area for the potential avoidance of malpractice claims and subsequent payouts involves misplaced pedicle and/or lateral mass instrumentation. 2021 Jul 1;41(Suppl 1):S80-S86. Spinal fusion procedures are increasingly performed each year, with Deyo et al. Complete degeneration of the upper disc developed in two patients who had spinal stenosis and degenerative scoliosis. Twenty-one patients (18.8%) had thoracolumbar injuries, and loss of immediate postoperative deformity correction ranged from 1.4 to 4.5. Start; O firmie; Usugi; Serwis; Realizacje i porady; Kontakt EOS System Courtesy of EOS imaging. The amount awarded was not significantly different across US regions (p = 0.9; Fig. 2022 Sep 15;14(9):6323-6331. eCollection 2022. Fortunately, most of the complications were minor and transient. To prevent general complications, it is evident that precise and careful soft tissue handling, proper irrigation, and debridement during and after surgery, decrease of operative time, and proper patient monitoring postoperatively must be done. 10. Please do not include any confidential or sensitive information in a contact form, text message, or voicemail. government site. Plaintiff award amounts were adjusted for inflation as of April 2020 using an online inflation calculator provided by the US Bureau of Labor Statistics (https://www.bls.gov/data/inflation_calculator.htm). Back pain/spinal stenosis and neurogenic claudication/radiculopathy were the most frequently reported indications for the index surgery, accounting for 13 (19.1%) and 11 (16.2%) cases, respectively. Clin Orthop 203:126134, 1986. Guzek RH, Mitchell SL, Krakow AR, Harshavardhana NS, Sarkissian EJ, Flynn JM. A TLIF is a surgical procedure that attempts to fuse vertebrae in order to stabilize the patient's spine. It is an effective procedure in that it provides an almost immediate stabilization of the spine [ 2-5 ]. The total number of reoperations for MPS and patient clinical data were obtained from medical records at each hospital. Background The objective of this cadaveric study was to analyze the effects of iatrogenic pedicle perforations from screw misplacement on the mean pullout strength of lower thoracic and lumbar pedicle screws. 0 attorneys agreed. In addition, seven (6.3%) dural tears occurred during the decompression and none occurred during instrumentation. sharing sensitive information, make sure youre on a federal Cerebrospinal fluid fistulas. Two patients had an acute infection develop for which they required operative intervention with irrigation and debridement. Katonis PG, Kontakis GM, Loupasis GA, et al: Treatment of unstable thoracolumbar and lumbar spine injuries using Cotrel-Dubousset instrumentation. Katonis, Pavlos MD*; Christoforakis, Joseph MD*; Aligizakis, Agisilaos C. MD*; Papadopoulos, Charalampos MD*; Sapkas, George MD, DSc**; Hadjipavlou, Alexander MD*. Under the high-low agreement, Drs. Clinical Orthopaedics and Related Research, Get new journal Tables of Contents sent right to your email inbox, The Association of Bone and Joint Surgeons, Complications and Problems Related to Pedicle Screw Fixation of the Spine, Articles in Google Scholar by Pavlos Katonis, MD, Other articles in this journal by Pavlos Katonis, MD, Privacy Policy (Updated December 15, 2022). 5. (A) Anteroposterior and (B) lateral radiographs taken 1 year after surgery show upper screw breakage in the application of a short Cotrel-Dubousset construct in a T12 burst fracture. Balch CM, Oreskovich MR, Dyrbye LN, et al. Forty-seven intraoperative and medical complications were observed in 41 patients (36.6%). 2018;28(2):186193. 2013;123(9):20992103. Smith TR, Hulou MM, Yan SC, et al. An official website of the United States government. A p < 0.05 was considered statistically significant. 8,24,25,32. All the incidental dural tears were repaired immediately and produced no clinical sequelae. On average, physicians spend nearly 11 percent of their 40-year careers with an open, unresolved malpractice claim. A review of medicolegal malpractice suits involving cervical spine: what can we learn or change? J Neurosurg Spine. Materials and Methods Sixty . The third surgical procedure removed the pedicle screws but left the patient in an unfused state with an unstable spine. J Neurosurg. With pedicle shapes and sizes varying wildly in the scoliotic spine, misplacement of a screwas well as and under- or oversizingare real possibilities in spine surgery. 2. Risk factor analysis showed smaller Cobb angles increased likelihood of all screws being AP. Mayo Clinic uses the latest robot-assisted technology when indicated to enhance surgical precision in these procedures. Linking and Reprinting Policy. Rothberg MB, Class J, Bishop TF, et al. 2005;293(21):26092617. Thirty-five (27.56%) had IMP and 18 (14.17%) had SAR.
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